Fianlimab (REGN3767) Emerging Drug Insight and Market Forecast – 2035

Fianlimab (REGN3767) Emerging Drug Insight and Market Forecast – 2035

“Fianlimab (REGN3767) Emerging Drug Insight and Market Forecast – 2035” report provides comprehensive insights about Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies in the 7MM. A detailed picture of the Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019–2035 is provided in this report along with a detailed description of the Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the Fianlimab (REGN3767) market forecast, analysis for LAG-3 Next-generation Immunotherapies in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in LAG-3 Next-generation Immunotherapies.

Drug Summary

REGN3767 is an immune checkpoint inhibitor that Regeneron Pharmaceuticals and Sanofi are developing to treat solid tumors and blood cancers. Immunotherapies like REGN3767 turn off immune system checkpoints. This boosts the immune response, increasing the body’s ability to fight cancer.

Fianlimab (REGN3767) is a fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T cells and was invented using Regeneron's proprietary VelocImmune technology. In melanoma, LAG-3 expression on cancer cells is associated with therapeutic resistance to PD-1 inhibitors. Fianlimab is being investigated in combination with Regeneron's PD-1 inhibitor Libtayo to determine whether concurrent blockade of LAG-3 and PD-1 can help overcome this resistance and release the brakes on T cell activation.

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the US and other countries, Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron.

In exploratory analysis of two expansion cohorts from a Phase I trial investigating fianlimab in combination with Libtayo in patients with advanced melanoma, which offer new insights on the use of this treatment combination in patients with poor prognostic features at baseline,

A Phase I trial in solid tumors and advanced hematological malignancies is currently underway at the company. The company anticipates filing an NDA in combination with Libtayo (cemiplimab) for advanced melanoma by 2024. Regeneron Pharmaceuticals also started a phase III trial for melanoma to evaluate the superiority of the Fianlimab and cemiplimab combination compared to pembrolizumab in adult and adolescent patients with completely resected high-risk skin cancer.

Mechanism of action

Regeneron and Sanofi designed REGN3767 to interact with an immune checkpoint protein called LAG-3 — for lymphocyte activation gene 3. LAG-3 is found on the surface of activated T-cells. Its interaction with MHC class 2 proteins turns off T-cells’ cell-killing ability and prevents their proliferation. This leads to a buildup of inactivated T-cells around a tumor, further reducing the immune response. By binding to LAG-3, REGN3767 blocks its ability to interact with MHC class 2 proteins. This prevents LAG-3 from inactivating T-cells. The result is an increase in the number of T-cells capable of killing cancer cells reducing tumor growth.

Scope of the Report

The report provides insights into:

A comprehensive product overview including the Fianlimab (REGN3767) description, mechanism of action, dosage and administration, research and development activities in LAG-3 Next-generation Immunotherapies.

Elaborated details on Fianlimab (REGN3767) regulatory milestones and other development activities have been provided in this report.

The report also highlights the Fianlimab (REGN3767) research and development activity in LAG-3 Next-generation Immunotherapies in detail across the United States, Europe and Japan.

The report also covers the patents information with expiry timeline around Fianlimab (REGN3767).

The report contains forecasted sales of Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies till 2035.

Comprehensive coverage of the late-stage emerging therapies for LAG-3 Next-generation Immunotherapies.

The report also features the SWOT analysis with analyst views for Fianlimab (REGN3767) in LAG-3 Next-generation Immunotherapies.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Fianlimab (REGN3767) Analytical Perspective by DelveInsight

In-depth Fianlimab (REGN3767) Market Assessment

This report provides a detailed market assessment of Fianlimab (REGN3767) in LAG-3 Next-generation Immunotherapies in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2026 to 2035.

Fianlimab (REGN3767) Clinical Assessment

The report provides the clinical trials information of Fianlimab (REGN3767) in LAG-3 Next-generation Immunotherapies covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

In the coming years, the market scenario for LAG-3 Next-generation Immunotherapies is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.

The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Fianlimab (REGN3767) dominance.

Other emerging products for LAG-3 Next-generation Immunotherapies are expected to give tough market competition to Fianlimab (REGN3767) and launch of late-stage emerging therapies in the near future will significantly impact the market.

A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Fianlimab (REGN3767) in LAG-3 Next-generation Immunotherapies.

Our in-depth analysis of the forecasted sales data from 2026 to 2035 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Fianlimab (REGN3767) in LAG-3 Next-generation Immunotherapies.

Key Questions

What is the product type, route of administration and mechanism of action of Fianlimab (REGN3767)?

What is the clinical trial status of the study related to Fianlimab (REGN3767) in LAG-3 Next-generation Immunotherapies and study completion date?

What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Fianlimab (REGN3767) development?

What are the key designations that have been granted to Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies?

What is the forecasted market scenario of Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies?

What are the forecasted sales of Fianlimab (REGN3767) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?

What are the other emerging products available in LAG-3 Next-generation Immunotherapies and how are they giving competition to Fianlimab (REGN3767) for LAG-3 Next-generation Immunotherapies?

Which are the late-stage emerging therapies under development for the treatment of LAG-3 Next-generation Immunotherapies?